To evaluate 5-year survival, functionality and safety for OsseoSpeed™ 3.0 mm diameter implant when used for single tooth crown in positions 12, 22, 31, 32, 41 and 42. The primary hypothesis is that implant survival after 5 years is equal to what has been observed with comparable implants in current literature.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Provision of informed consent
* Aged 18-70 years at enrolment
* History of edentulism in the study area of at least two months
* Presence of natural tooth roots adjacent to the study implant position
* Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
* Deemed by the investigator as likely to present an initially stable implant situation
Exclusion Criteria:
* Unlikely to be able to comply with study procedures, as judged by the investigator
* Uncontrolled pathologic processes in the oral cavity
* Known or suspected current malignancy
* History of radiation therapy in the head and neck region
* History of chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
* Uncontrolled diabetes mellitus
* Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
* Smoking more than 10 cigarettes per day
* Present alcohol and/or drug abuse
* Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
* Previous enrolment in the present study
* Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrolment
What they're measuring
1
Implant Survival Rate
Timeframe: Evaluated at implant placement and at the 5 years follow-up after implant placement